Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Denver Health and Hospital Authority

Status: Completed

Conditions: Tibia Fracture

Treatments: Procedure: No Splinting; Procedure: Post-Op Splinting

Study type: Interventional

Funder types: Other

Identifiers

NCT00888550

DHMC07-0216

Details and patient eligibility

About

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.

The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

Exclusion criteria

• Pregnant Women
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1. Splinting

Experimental group

Treatment:

Procedure: Post-Op Splinting

2. No Splinting

Active Comparator group

Treatment:

Procedure: No Splinting